MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS PROCEDURAL KIT; CELLEX KIT

Model Number CELLEX

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2016

Event Type  Injury  

Event Description

Failure to prime the cellex photopheresis device due to multiple "prime 4" alarms.Event reported to the mfr.Another kit was installed and prime completed without alarms.The kit was saved to be returned to the mfr for investigation.Reason for use: gvhd of the skin/photopheresis.Mallinkrodt pharmaceuticals,(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS PROCEDURAL KIT
• Type of Device: CELLEX KIT
• Manufacturer (Section D): THERAKOS, INC.
• MDR Report Key: 6232823
• MDR Text Key: 64265593
• Report Number: MW5067121
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2018
• Device Model Number: CELLEX
• Device Catalogue Number: CLXUSA
• Device Lot Number: E312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention